Catheter handle with torque mechanism and valve relief component

ABSTRACT

A catheter includes a handle with torqueing and steering mechanisms. The torqueing mechanism includes a rotatable nosecone and a bearing coupled to the nosecone to be rotatable therewith. The bearing is concentrically disposed over a shaft of the catheter. The steering mechanism includes a rack coupled to the bearing to be slideable therewith and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. Rotation of the nosecone causes an entire length of the shaft to rotate and axial movement of the rack tensions the pull wire to bend the distal portion of the shaft. A valve relief component is slidingly disposed over the shaft and is configured to dock onto the handle when not in use.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 17/897,663, filed Aug. 29, 2022, which is a continuation ofU.S. patent application Ser. No. 16/907,466, filed Jun. 22, 2020, nowU.S. Pat. No. 11,446,470, which claims the benefit of U.S. ProvisionalPatent Application Ser. No. 62/865,437, filed Jun. 24, 2019, each ofwhich is hereby incorporated by reference in its entirety for allpurposes. This application also claims the benefit of U.S. ProvisionalPatent Application Ser. No. 63/293,621, filed Dec. 23, 2021, which isalso hereby incorporated by reference in its entirety for all purposes.

FIELD OF THE INVENTION

Embodiments hereof relate to catheters and more particularly to handlesof a catheter or a delivery system.

BACKGROUND OF THE INVENTION

A variety of catheters for delivering a therapy and/or monitoring aphysiological condition have been implanted or proposed for implantationin patients. Catheters may deliver therapy to, and/or monitor conditionsassociated with, the heart, muscle, nerve, brain, stomach or otherorgans or tissue. Many catheters are tracked through the vasculature tolocate a therapeutic or diagnostic portion of the catheter at a targetsite. Such catheters must have flexibility to navigate the twists andturns of the vasculature, sufficient stiffness in the proximal portionthereof to be pushed through the vasculature alone or over a guidewireor through a lumen, and the capability of orienting a distal portionthereof in alignment with an anatomical feature at the target site sothat a diagnostic or therapeutic procedure can be completed. In generalterms, the catheter body must also resist kinking and be capable ofbeing advanced through access pathways that twist and turn, sometimesabruptly at acute angles.

For certain procedures, it may be necessary for the clinician toaccurately steer or deflect the catheter so that a distal openingthereof may be aligned with an ostium of a branch or side vessel. Thedistal portions of catheters frequently need to be selectively curved orbent and straightened again while being advanced within the patient tosteer the catheter distal end into a desired body lumen or chamber. Forexample, it may be necessary to direct the catheter distal end throughtortuous anatomies and/or into a branch at a vessel bifurcation. Inaddition, some procedures require high accuracy in guidewireorientation. For example, often patient's arteries are irregularlyshaped, highly tortuous and very narrow. The tortuous configuration ofthe arteries may present difficulties to a clinician in advancement of acatheter to a treatment site.

In addition to bending or deflecting the distal portion of the catheterduring navigation, the clinician may also need to rotate or torque thecatheter when advancing the catheter to a treatment site in order toachieve proper or desired alignment of the catheter. Currently,clinicians grasp and rotate the entire handle of the catheter in orderto manually torque the catheter. However, manually torqueing the entiredevice causes unstable movement of the catheter while inside the patientand may require significant force to combat recoiling forces.Additionally, when the handle of the catheter is rotated duringtorqueing, the controls on the handle may be placed in a position thatlimit the ability to use them.

Thus, a need in the art still generally exists for improved apparatusesand methods for navigating a catheter through or within a patient'sanatomy.

BRIEF SUMMARY OF THE INVENTION

Embodiments hereof also relate to a catheter including a handle and ashaft extending from within the handle, wherein the handle includes ahousing, a torqueing mechanism disposed at least partially within aninterior of the housing of the handle, and a steering mechanism disposedat least partially within the interior of the housing of the handle. Thetorqueing mechanism includes a nosecone rotatable relative to thehousing of the handle and a bearing coupled to the nosecone to berotatable therewith. The bearing is concentrically disposed over theshaft and is configured to transmit a torque from the nosecone to theshaft when the nosecone is rotated via a contoured inner surface of thebearing. The steering mechanism includes a rack and a pull wire having aproximal end attached to the bearing and a distal end attached to adistal portion of the shaft. The rack is coupled to the bearing suchthat the bearing is slideable therewith. Rotation of the nosecone causesan entire length of the shaft to rotate therewith and the bearingrotates relative to the rack during rotation thereof, and axial movementof the rack tensions the pull wire to bend the distal portion of theshaft and the bearing slides relative to the shaft and relative to thenosecone during axial movement thereof.

In an aspect of the first embodiment, and in combination with any otheraspects herein, the disclosure provides that the contoured inner surfaceincludes a plurality of protrusions.

In an aspect of the first embodiment, and in combination with any otheraspects herein, the disclosure provides that a bearing interface isdisposed over a portion of the shaft, the bearing interface including aplurality of grooves. The plurality of protrusions are configured to bereceived within the plurality of grooves.

In an aspect of the first embodiment, and in combination with any otheraspects herein, the disclosure provides that the plurality ofprotrusions are permitted to slide within the plurality of grooves.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other features and advantages of the invention will beapparent from the following description of embodiments hereof asillustrated in the accompanying drawings. The accompanying drawings,which are incorporated herein and form a part of the specification,further serve to explain the principles of the invention and to enable aperson skilled in the pertinent art to make and use the invention. Thedrawings are not to scale.

FIG. 1 is a side view of a catheter or delivery system according to anembodiment hereof, wherein the catheter includes a handle including botha torqueing mechanism and a steering mechanism and wherein the catheterincludes a balloon-expandable prosthesis disposed at a distal portionthereof.

FIG. 2 is a side view of the distal portion of the catheter of FIG. 1 ,wherein the distal portion is bent in a first direction via the steeringmechanism of the handle of the catheter.

FIG. 3 is a side view of the distal portion of the catheter of FIG. 1 ,wherein the distal portion is bent in a second or opposing direction viathe steering mechanism of the handle of the catheter.

FIG. 4 is a perspective view of the handle of the catheter of FIG. 1 ,wherein a shell or housing of the handle is removed for illustrativepurposes.

FIG. 5 is an exploded perspective view of the handle of the catheter ofFIG. 1 .

FIG. 6 is a side view of a distal portion of the handle of the catheterof FIG. 1 , wherein a portion of the housing, a nosecone, and a lockingmechanism of the handle are shown with the remaining components removedfor illustrative purposes.

FIG. 7 is a perspective view of a slider of the locking mechanism of thehandle of the catheter of FIG. 1 , wherein the slider is removed fromthe handle for illustrative purposes.

FIG. 8A is a perspective view of a portion of a shaft of the catheter ofFIG. 1 and a strain relief segment disposed over the shaft, wherein theshaft and the strain relief segment are removed from the catheter forillustrative purposes.

FIG. 8B is another perspective view of the portion of the shaft of thecatheter of FIG. 1 and the strain relief segment disposed over theshaft, wherein the shaft and the strain relief segment are removed fromthe catheter for illustrative purposes.

FIG. 9A is a perspective view of a portion of the nosecone of the handleof the catheter of FIG. 1 , wherein the nosecone is removed from thehandle for illustrative purposes.

FIG. 9B is a perspective view of a distal portion of the nosecone of thehandle of the catheter of FIG. 1 , wherein the nosecone is removed fromthe handle for illustrative purposes.

FIG. 10 is a perspective view of a bearing of the handle of the catheterof FIG. 1 , wherein the bearing is removed from the handle forillustrative purposes.

FIG. 10A is a side view of the bearing of the handle of the catheter ofFIG. 1 , wherein the bearing is removed from the handle for illustrativepurposes.

FIG. 10B is a front view of the bearing of the handle of the catheter ofFIG. 1 , wherein the bearing is removed from the handle for illustrativepurposes.

FIG. 10C is a front view of a bearing according to another embodimenthereof, wherein the bearing includes a contoured inner surface.

FIG. 10D is a perspective view of a bearing interface to be used withthe bearing of FIG. 10C, wherein the bearing interface is removed fromthe handle for illustrative purposes.

FIG. 10E is a front view of the bearing of FIG. 10C disposed over thebearing interface of FIG. 10D.

FIG. 11 is a perspective view of an assembly of the nosecone and thebearing of the handle of the catheter of FIG. 1 , wherein the assemblyis removed from the handle for illustrative purposes.

FIG. 12 is a perspective view of a rack of the handle of the catheter ofFIG. 1 , wherein the rack is removed from the handle for illustrativepurposes.

FIG. 13 is a perspective view of a knob of the handle of the catheter ofFIG. 1 , wherein the knob is removed from the handle for illustrativepurposes.

FIG. 14 is a perspective view of an assembly of the rack and the knob ofthe handle of the catheter of FIG. 1 , wherein the assembly is removedfrom the handle for illustrative purposes.

FIG. 15 is a side view of an assembly of the rack and the bearing of thehandle of the catheter of FIG. 1 , wherein the assembly is removed fromthe handle for illustrative purposes.

FIG. 16 is a perspective view of the housing or shell of the handle ofthe catheter of FIG. 1 , wherein the housing is removed from the handlefor illustrative purposes.

FIG. 17 is a side sectional view of the handle of the catheter of FIG. 1, wherein a portion of the housing and the nosecone are removed forillustrative purposes.

FIG. 18 is a perspective view of the catheter of FIG. 1 , wherein thehousing of the handle is removed for illustrative purposes and a pullwire of the steering mechanism is shown in phantom within the catheter.

FIG. 19 is an enlarged view of a portion of FIG. 18 , wherein theenlarged view depicts the pull wire exiting from the shaft and beingattached to the bearing within the handle.

FIG. 20 is a side view of a valve relief component that may be utilizedwith the catheter of FIG. 1 .

FIG. 21 is a side view of the valve relief component of FIG. 20slidingly disposed over the shaft of the catheter of FIG. 1 .

FIG. 22 is a side view of the distal portion of the catheter of FIG. 1 ,wherein the valve relief component of FIG. 20 is disposed over theballoon-expandable prosthesis.

FIG. 23 is a side view of the distal portion of the catheter of FIG. 1 ,wherein the catheter is being inserted through an introducer sheath withthe valve relief component of FIG. 20 disposed over theballoon-expandable prosthesis.

FIG. 24 is a side view of the catheter of FIG. 21 , wherein the valverelief component of FIG. 20 is docked onto the strain relief componentof the handle of the catheter.

FIG. 25A is a side view of another configuration of a valve reliefcomponent that may be utilized with the catheter of FIG. 1 .

FIG. 25B is a side view of the distal portion of the catheter of FIG. 1, wherein the valve relief component of FIG. 25 is disposed over theballoon-expandable prosthesis.

FIG. 25C is a side view of the distal portion of the catheter of FIG. 21, wherein the valve relief component of FIG. 25 is docked onto thestrain relief component of the handle of the catheter.

FIG. 26 is a perspective view of the strain relief component of thehandle of the catheter of FIG. 1 , wherein the strain relief componentis removed from the catheter for illustrative purposes.

FIG. 27 is a perspective view of another configuration of a strainrelief component that may be utilized in embodiments hereof.

FIG. 28 is a perspective view of another configuration of a strainrelief component that may be utilized in embodiments hereof.

FIG. 29 is a perspective view of another configuration of a strainrelief component that may be utilized in embodiments hereof.

FIG. 30 is a perspective view of a magnetic coupling that may beutilized in embodiments hereof.

FIG. 31 is a perspective view of a nosecone and the shaft according toanother embodiment hereof, wherein the shaft and the nosecone arecoupled together such that the nosecone causes rotation of the shaft.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the present invention are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. The terms “distal” and“proximal” are used in the following description with respect to aposition or direction relative to the treating clinician. “Distal” or“distally” are a position distant from or in a direction away from theclinician. “Proximal” and “proximally” are a position near or in adirection toward the clinician. In addition, “slidably” or “slidable”denotes back and forth movement in a longitudinal direction about alongitudinal axis LA of the handle (shown in FIG. 1 ) while “rotatably”or “rotatable” denotes movement or rotation about the longitudinal axisLA of the handle.

The following detailed description is merely exemplary in nature and isnot intended to limit the invention or the application and uses of theinvention. Although the description of the invention is in the contextof delivery of a balloon-expandable prosthesis, the invention may alsobe used where it is deemed useful in endoscopic procedures, proceduresin the coronary vessels, or procedures in the peripheral vessels.Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the preceding technical field, background,brief summary or the following detailed description.

Embodiments hereof relate to a handle for a delivery catheter or othercatheter device, the handle including a torqueing mechanism. Thetorqueing mechanism includes a nosecone rotatable relative to thehousing of the handle and a bearing coupled to the nosecone to berotatable therewith. The bearing is concentrically disposed over a shaftof the catheter and is configured to transmit a torque from the noseconeto the shaft when the nosecone is rotated. Rotation of the noseconecauses an entire length of the shaft to rotate therewith. The handlethus has the capability of torqueing the entire length of the shaft withan actuator (i.e., the rotatable nosecone), circumferentially to anexact degree, allowing for increased stability of the handle during use.Stated another way, the handle itself does not need to be twisted orrotated in order to direct the distal tip of the shaft and thus othercontrols or actuators on the handle remain stationary and accessible tothe user during the procedure. The handle also includes a steeringmechanism to apply tension on a pull wire to bend a distal portion ofthe shaft, with both the torqueing and steering mechanisms integratedinto the handle such that operation of the torqueing mechanism does notinterfere with operation of the steering mechanism. In addition, thecatheter further includes a valve relief component that serves also torelieve strain of the distal portion of the catheter when the catheteris inserted through an introducer sheath. The valve relief component maybe secured onto the handle after insertion through the introducer sheathto ensure it does not slide on the catheter during the procedure.

The catheter will now be described in more detail with reference to thefigures. With reference to FIG. 1 , a catheter 100 includes a handle 112and a shaft 102 having a distal end 106 opposite the handle 112. Thehandle 112 includes both a torqueing mechanism 116 and a steeringmechanism 144 as will be described in greater detail herein. Shaft 102defines a central lumen 110 such that catheter 100 may be slidinglydisposed and track over a guidewire (not shown). Shaft 102 may furtherdefine additional lumens depending upon the particular configuration ofthe catheter 100. A balloon-expandable prosthesis 101 is mounted over aballoon 105 disposed on a distal portion of the shaft 102. Theballoon-expandable prosthesis 101 is shown in its delivery or unexpandedconfiguration in FIG. 1 , but it will be understood by those of ordinaryskill in the art that after deployment, the balloon-expandableprosthesis 101 is radially expanded or deployed by the balloon 105 andreleased from the catheter 100 at a desired location in a patient's bodylumen. The configuration of the balloon-expandable prosthesis 101 ismerely exemplary, and it would be apparent to one of ordinary skill inthe art that catheter 100 may be utilized for delivering and deployingvarious types or configurations of prostheses. Further, althoughdepicted as a delivery catheter for the balloon-expandable prosthesis101, the catheter 100 is not required to be configured for delivering aprosthesis but rather the catheter 100 having the handle 112 may beutilized in other procedures or for other purposes including diagnosticpurposes. The handle 112 having both the torqueing mechanism 116 and thesteering mechanism 144 is advantageous in any type of catheter that mayrequire torqueing and/or steering during navigation in situ. Althoughthe catheter 100 described herein is a stand-alone delivery catheter fordelivering the balloon-expandable prosthesis 101, in another embodimenthereof (not shown), the catheter 100 forms an outer component of anothertype of treatment or delivery system.

The torqueing mechanism 116 permits the distal portion of the catheter100 to be rotated as indicated by the directional arrow 117 by turning anosecone 118 disposed at the distal end of the handle 112 while holdingthe proximal end of the handle 112 which contains the remainingcontrols. The steering mechanism 144 includes a pull wire 146 (shown onFIGS. 18 and 19 ) which is attached to the distal end 106 of the shaft102 to be selectively tensioned in order to bend the distal end 106 ofthe catheter. The pull wire 146 is configured to rotate to the samedegree as the shaft 102 when the catheter 100 is being torqued viarotation of the nosecone 118. When the pull wire 146 is retracted viathe steering mechanism 144, the pull wire 146 is placed under tension tobend or deflect the distal portion of the catheter 100. For example,FIG. 2 is a side view of the distal portion of the catheter 100 thatillustrates the distal portion of the catheter 100 bent in a firstdirection via the steering mechanism 144 as illustrated by directionalarrow 145A. If it is desired to bend or deflect the distal portion ofthe catheter 100 in an opposing direction (i.e., a second directionopposite from the first direction as illustrated by directional arrow145B in FIG. 3 ), the torqueing mechanism 116 may be actuated to rotatethe catheter approximately 180 degrees and then the steering mechanism144 may be actuated to bend the distal portion of the catheter 100.

The handle 112 includes a housing or shell 114 which houses the internalcomponents of the handle 112. The components of the handle 112 will nowbe introduced with reference to FIGS. 4 and 5 , with FIG. 4 being aperspective view of the handle 112 with the housing 114 thereof removedfor illustrative purposes and FIG. 5 being an exploded perspective viewof the handle 112. In addition to the housing 114, the handle 112includes the nosecone 118 which is rotatable relative to the housing114, a bearing 126 which is disposed within the housing 114 and isconcentrically disposed over the shaft 102, a rack 134 coupled to thebearing 126, the pull wire 146 (shown on FIGS. 18 and 19 ), a lockingmechanism 158, a strain relief component 170 disposed over a portion ofthe shaft 102 at a distal end of the housing 114, and a luer fitting 178disposed over a portion of the shaft 102 at a proximal end of thehousing 114. The luer fitting 178 is attached to the housing 114 and theshaft 102 is disposed through the luer fitting 178 such that the shaft102 is configured to freely rotate or spin within the luer fitting 178and thus be rotatable relative to the housing 114.

With additional reference to FIGS. 6 and 7 , the locking mechanism 158is configured to lock a circumferential position of the nosecone 118relative to the housing 114 of the handle 112. FIG. 6 is a side view ofa distal portion of the handle 112, wherein a portion of the housing114, the nosecone 118, and the locking mechanism 158 are shown with theremaining components removed for illustrative purposes. FIG. 7 is aperspective view of a slider 160 of the locking mechanism 158 removedfrom the handle 112 for illustrative purposes. The locking mechanism 158includes the slider 160 accessible and operable from an exterior of thehousing 114 of the handle 112 and a spring 168 disposed within a recesswithin the housing 114. A proximal end 164 of the slider 160 abutsagainst and contacts the spring 168. The slider 160 has a tooth orpointed tip 166 formed at a distal end 162 thereof that is configured toselectively engage or mate with a plurality of teeth 122 formed on aproximal end surface 120 of the nosecone 118. When the pointed tip 166of the slider 160 engages or mates with one of the plurality of teeth122 of the nosecone 118, the nosecone 118 is in a locked configurationand cannot be rotated or spun by the user. Stated another way, thepointed tip of the slider 160 fits into one of the plurality of teeth122 of the nosecone 118 to hold the nosecone 118 in the lockedconfiguration. As such, the slider 160 locks a circumferential positionof the nosecone 118 relative to the housing 114 of the handle 112. Auser is thus prevented from inadvertently spinning or rotating thenosecone 118 when the nosecone 118 is in the locked configuration.

When it is desired to torque the shaft 102 of the catheter 100, theslider 160 is proximally retracted such that the pointed tip 166 of theslider 160 is withdrawn from the teeth 122 of the nosecone 118, therebyreleasing the nosecone 118 to be in an unlocked configuration. Whenretracted in a proximal direction, the slider 160 compresses the spring168 and is permitted to move in a proximal direction to disengage fromthe nosecone 118. When in the unlocked configuration, the nosecone 118may be rotated in order to torque the catheter 100. Once the catheter100 is torqued as desired, the user may release the slider 158 such thatthe spring 168 resumes its uncompressed configuration, thereby distallyadvancing the slider 158 to re-engage with the nosecone 118 such thatthe pointed tip 166 of the slider 160 is positioned within one of theplurality of teeth 122 of the nosecone 118. Stated another way, when theslider 160 is released, the tension within the spring 168 and thesufficient resiliency of the spring 168 causes the slider 160 to movedistally and contact the proximal end surface 120 of the nosecone 118,thereby securing the nosecone 118 in its locked configuration.

FIGS. 8A and 8B are perspective views of a portion of the shaft 102 andthe strain relief component 170 removed from the catheter 100 forillustrative purposes. The shaft 102 is an elongate tubular orcylindrical element defining the central lumen 110 that extends from aproximal end 104 to the distal end 106 thereof. The central lumen 110 isopen at the distal end 106 of the shaft 102 which in turn forms thedistal end of the catheter 100. In an embodiment hereof, the centrallumen 110 is sized or configured to slidingly receive a guidewirethere-through. The shaft 102 includes an elongated slot or channel 108formed through a sidewall thereof. The elongated slot 108 is disposedwithin the handle 112, distal to the bearing 126, and functions topermit the pull wire 146 to exit from within the central lumen 110 aswill be described in more detail herein with respect to FIGS. 18 and 19. In an embodiment, the shaft 102 may be sized to be used with anintroducer sheath with the central lumen 110 being sized to accommodatea guidewire having an outer diameter of 0.035 inch. The proximal end 104of the shaft 102 extends out of the patient and is disposed within thehandle 112.

The shaft 102 also includes an inflation lumen (not shown) to allowinflation fluid to be delivered to the balloon. In an embodiment, theinflation lumen is preformed in a sidewall of the shaft 102 and may beformed for example by multi-lumen profile extrusion. The inflation lumenextends adjacent or parallel to the central lumen 110 but terminates atthe balloon 105, proximal to the distal end 106 of the shaft 102. Theinflation lumen is in fluid communication with an interior of theballoon 105 to permit inflation fluid to be delivered to the interior ofthe balloon 105 and radially expand the balloon 105 when desired. Inanother embodiment, the inflation lumen may alternatively be formed viaan annular space formed between an inner shaft component concentricallydisposed within the shaft 102, or via an elongated inflation tubedisposed within and attached to the shaft 102, as will be understood bythose of ordinary skill in the art of balloon catheter construction. Itwould also be understood by one of ordinary skill in the art of ballooncatheter design that the luer fitting 178, or some other type offitting, may be connected to a source of inflation fluid (not shown) andmay be of another construction or configuration without departing fromthe scope of the present invention.

The shaft 102 may be formed of one or more polymeric materials,non-exhaustive examples of which include polyethylene, polyethyleneblock amide copolymer (PEBA), polyamide and/or combinations thereof,either laminated, blended or co-extruded. Optionally, the shaft 102 orsome portion thereof may be formed as a composite having a reinforcementlayer incorporated within a polymeric body in order to enhance strengthand/or flexibility. Suitable reinforcement layers include braiding, wiremesh layers, embedded axial wires, embedded helical or circumferentialwires, hypotubes, and the like. In one embodiment, for example, at leasta proximal portion of the shaft 102 may be formed from a reinforcedpolymeric tube. In accordance with embodiments hereof, the balloon 105may be formed of any suitable polymeric material used for dilatationballoon manufacturing, for instance, polyether block amide (PEBA) andpolyurethane (PU), and may have an outer diameter in the range of 2-4 mmand a length in the range of 5-15 mm.

The strain relief component 170 is concentrically disposed over aportion of the shaft 102 at a distal end of the housing 114 andfunctions to relieve stress from the shaft 102 as it exits from thedistal end of the housing 114. The strain relief component 170 may beformed as a separate component and disposed on an outer surface of theshaft 102 via any suitable mechanical method such as laser welding, heatwelding, over-molding, adhesive binding, or other mechanical lockingfeature such as a threaded interface or a snap fit feature. The strainrelief component 170 is secured or fixed to the outer surface of theshaft 102 so as to move as a single or unitary assembly. Stated anotherway, the strain relief component 170 is fixed relative to the shaft 102such that they cannot move rotationally or axially relative to eachother. The strain relief component 170 is a relatively short tubularcomponent that defines a lumen therethrough that extends from a proximalend 174 to a distal end 176 thereof. The proximal end 174 includes aradial flange 175 that is attached to the interior of the nosecone 118.The distal end 176 of the strain relief component 170 extends orprotrudes from a distal end of the housing 114 of the handle 112 andincludes a circumferential bump or raised ring 177 that is configured tomate with a valve relief component as will be described in more detailherein with respect to FIGS. 20-30 . As will be described in more detailherein, the valve relief component is a component that is slidinglydisposed over an outer surface of the shaft 102 and is configured to beselectively disposed over the balloon-expandable prosthesis 101 toprotect the balloon-expandable prosthesis 101 during insertion into anintroducer sheath. The strain relief component 170 is configured toserve as a docking station for the valve relief component when the valverelief component is not disposed over the balloon-expandable prosthesis101. The valve relief component is secured or docked onto the raisedring 177 of the strain relief component 170 through an interference fit.

The torqueing mechanism 116 of the handle 112 will now be described inmore detail. The torqueing mechanism 116 includes the nosecone 118 andthe bearing 126, which are rotatably coupled together such that rotationof the nosecone 118 also results in rotation of the bearing 126. Thebearing 126 is also rotatably coupled to the shaft 102 such thatrotation of the bearing 126, which is concentrically disposed over theshaft 102, further results in rotation of the shaft 102. Thus, thetorqueing mechanism 116 permits the distal portion of the catheter 100to be rotated by turning a nosecone 118 of the handle 112.

More particularly, FIGS. 9A and 9B illustrate the nosecone 118 removedfrom the handle 112 for illustrative purposes only. FIG. 9A is aperspective sectional view of the nosecone 118 and FIG. 9B is aperspective view of a distal portion of the nosecone 118. The nosecone118 is accessible and operable from an exterior of the housing 114. Thenosecone 118 has a truncated hollow conical configuration such that theshaft 102 extends therethrough. The proximal end surface 120 of thenosecone 118 includes the plurality of teeth 122 that interact with thelocking mechanism 158 as described above with respect to FIGS. 6 and 7 .The nosecone 118 also includes a circumferential groove 119 formed on anouter surface thereof for coupling the nosecone 118 to a distal end ofthe housing 114. The nosecone 118 further includes first and secondfingers 124A, 124B proximally extending from the proximal end surface120 of the nosecone 118. The first and second fingers 124A, 124B aredisposed at circumferentially opposing locations of the nosecone 118,and serve to couple the nosecone 118 to the bearing 126 as best shown inFIG. 11 which is an assembly of the nosecone 118 and the bearing 126.

FIGS. 10, 10A, and 10B illustrate the bearing 126 removed from thehandle 112 for illustrative purposes only. FIG. 10 is a perspective viewof the bearing 126, which FIG. 10A is a side view and FIG. 10B is afront view. The bearing 126 is disposed within the interior of thehousing 114 of the handle 112. The bearing 126 is a tubular componentthat defines a lumen 128 therethough. The bearing 126 is concentricallydisposed over the shaft 112 such that the shaft 112 extends through thelumen 128. The bearing 126 also includes a radial flange 130 at aproximal end thereof. The radial flange 130 includes first and secondslots 132A, 132B formed therethrough. The first and second slots 132A,132B are sized and configured to receive the first and second fingers124A, 124B, respectively, of the nosecone 118. The first and secondfingers 124A, 124B will extend through and be secured within the firstand second slots 132A, 132B, respectively, through an interference fitas best shown in FIG. 11 which is an assembly of the nosecone 118 andthe bearing 126. Via the first and second fingers 124A, 124B, thebearing 126 is coupled to the nosecone 118 to be rotatable therewith.

The bearing 126 is configured to transmit a torque or a drive to theshaft 102 when the bearing 126 is rotated. The bearing 126 transmits atorque from the nosecone 118 to the shaft 102 when the nosecone 118 isrotated in either direction, i.e., counter-clockwise or clockwise. Thus,when the nosecone 118 is rotated by a user, the bearing 126 and theshaft 102 rotate with the nosecone 118. Rotation of the nosecone 118causes an entire length of the shaft 102 to rotate therewith, and thusthe torqueing mechanism 116 may be utilized to torque the distal portionof the catheter 100.

In embodiments hereof, the bearing 126 transmits a torque or a drive tothe shaft 102 when the bearing 126 is rotated via sufficient contactbetween an inner surface of the bearing 126 and an outer surface of theshaft 102. Stated another way, the bearing 126 is coupled to the shaft102 through an interference or friction fit such that rotation of thebearing 126 causes rotation of the shaft 102. However, as will bedescribed in more detail below, the bearing 126 is also slidablerelative to the shaft 102. When the bearing 126 is axially translatedvia the rack 134 as further described with respect to FIGS. 12-15 , theapplied axial force overcomes the friction fit and the bearing 126slides over the shaft 102. The proximal portion of the shaft 102 isstationary during axial movement of the rack 134 and the bearing 126,while the distal portion of the shaft is bent via tensioning of the pullwire 146. The shaft 102 is coupled to the handle 112 such that axialmovement of the shaft 102 is prohibited, and/or the shaft 102 may beheld stationary during axial movement of the rack 134 and the bearing126 via user-applied force to the shaft 102 external to the handle 112.In an embodiment, the shaft 102 may be attached to the nosecone 118 suchthat axial movement of the shaft 102 is prohibited. With reference toFIG. 9A, the nosecone 118 may include an internal flange 131. The radialflange 175 of the strain relief component 170 abuts against the internalflange 131 of the nosecone 118, thereby prohibiting any axial movementin the distal direction of the strain relief component 170 and the shaft102 secured thereto.

In another embodiment, the bearing 126 is a roller-type bearing in whichtorque is positively transmitted by rollers (not shown) that wedgeagainst interior ramps or may be another type of bearing known in theart. For example, the bearing 126 may be a roller or ball spline bearingthat is capable of transmitting torque while also permitting axialtranslation or motion.

Other configurations of the bearing 126 are contemplated herein, and theconfiguration of the bearing 126 is not limited to the configurationshown in FIGS. 10-10B. FIG. 10C is a front view of another embodiment ofa bearing 126C that may be utilized in embodiments hereof. The bearing126C is a tubular component that defines a lumen 128C there though.Similar to the bearing 126, the bearing 126C also includes a radialflange 130C at a proximal end thereof. The radial flange 130C includesfirst and second slots 132C, 132D formed therethrough. Similar to thefirst and second slots 132A, 132B of the bearing 126, the first andsecond slots 132C, 132C are sized and configured to receive the firstand second fingers 124A, 124B, respectively, of the nosecone 118. Viathe first and second fingers 124A, 124B, the bearing 126C is coupled tothe nosecone 118 to be rotatable therewith.

An inner surface 121C of the bearing 126C includes a plurality ofprotrusions 123C to form a contoured inner surface. In this embodiment,the shaft 102 includes a bearing interface 125 on an outer surfacethereof. The bearing interface 125 and the shaft 102 are shown removedfrom all other components in FIG. 10D for illustrative purposes only.The bearing interface 125 may be formed as a separate component anddisposed on an outer surface of the shaft 102 via any suitablemechanical method such as laser welding, heat welding, over-molding,adhesive binding, or other mechanical locking feature such as a threadedinterface or a snap fit feature. The bearing interface 125 is secured orfixed to the outer surface of the shaft 102 so as to move as a single orunitary assembly. Stated another way, the bearing interface 125 is fixedrelative to the shaft 102 such that they cannot move rotationally oraxially relative to each other. In another embodiment hereof, thebearing interface 125 may be integrally formed on an outer surface ofthe shaft 102. The bearing interface 125 has an outer surface 127 with ascalloped configuration including a plurality of grooves 129A and aplurality of ridges 129B. Each groove 129A is formed between a pair ofadjacent ridges 129B. The bearing 126C is disposed over the bearinginterface 125 and each groove 129A of the bearing interface 125 isconfigured or sized to receive a protrusion 123C of the bearing 126C.The scalloped configuration of the outer surface 127 of the bearinginterface 125 is exemplary and the number of the plurality of grooves129A and the plurality of ridges 129B may vary from that shown herein.For example, the bearing interface 125 may include a fewer number ofalternating ridges and grooves than shown, and the ridges and groovesare not required to be equally spaced around the outer surface 127 ofthe bearing interface 125.

With reference to FIG. 10E, which is a front view of the bearing 126Cand the bearing interface 125 disposed there through, the bearinginterface 125 is configured to transmit a torque or a drive to the shaft102 when the bearing 126C is rotated. Due to the mating relationshipbetween the protrusions 123C of the bearing 126C and the grooves 129A ofthe bearing interface 125, the amount of contact between the innersurface 121C of the bearing 126C and the outer surface 127 of the shaft102 is relatively increased (as compared to the bearing 126 which doesnot have a contoured inner surface) and thus torque transmission betweenthe bearing 126C and the shaft 102 may be relatively improved. Theprotrusions 123C mechanically interlock with the grooves 129A when thebearing 126C is rotated, abutting against the outer surface 127 formedby the grooves 129A and the ridges 129B, thereby improving torquetransmission from the bearing 126C to the shaft 102. The bearing 126Ctransmits a torque from the nosecone 118 to the shaft 102 when thenosecone 118 is rotated in either direction, i.e., counter-clockwise orclockwise. Rotation of the nosecone 118 causes an entire length of theshaft 102 to rotate therewith, and thus rotation of the nosecone 118 maybe utilized to torque the distal portion of the catheter 100. Notably,the mating contact between the inner surface 121C of the bearing 126Cand the outer surface 127 of the shaft 102 still permits axialtranslation of the shaft 102 because the protrusions 123C of the bearinginterface 125 are permitted to slide within the grooves 129A of thebearing 126C.

The bearings 126, 126C may be formed from any suitable polymericmaterial. In an embodiment, the bearings 126, 126C may be formed from afluoropolymer including but not limited to polytetrafluoroethylene.

The steering mechanism 144 of the handle 112 will now be described inmore detail. The steering mechanism 144 includes a knob 152 which isrotatable relative to the housing 114 of the handle 112, the rack 134concentrically disposed within the knob 152 and coupled to the bearing126, and the pull wire 146 (shown and described with respect to FIGS. 18and 19 below). The pull wire 146 is attached to the distal end 106 ofthe shaft 102 to be selectively tensioned in order to bend the distalend 106 of the catheter. Stated another way, when the pull wire 146 isretracted via the steering mechanism 144, the pull wire 146 is placedunder tension and bends the distal portion of the catheter 100.

FIG. 12 illustrates a perspective view of the rack 134 removed from thehandle 112 for illustrative purposes only. The rack 134 is a tubularcomponent defining a lumen 136 therethrough such that the shaft 102extends through the rack 134. The rack 134 is disposed within aninterior of the housing 114 of the handle 112. The rack 134 includes aseries of protrusions 140 formed on an outer surface 138 thereof forinteracting with the knob 152 as will be explained in more detailherein. The rack 134 also includes first and second tabs or clips 142A,142B that distally extend from a distal end of the rack 134. The firstand second clips 142A, 142B are disposed at circumferentially opposinglocations of the rack 134, and serve to couple the rack 134 to thebearing 126 as best shown in FIG. 15 which is a side view of an assemblyof the rack 134 and the bearing 126. As shown in FIG. 15 , the rack 134is disposed abutting against or directly adjacent to the bearing 126with the bearing 126 distally extending or protruding from the distalend of the rack 134. The first and second clips 142A, 142B extend overthe radial flange 130 and couple the bearing 126 to the rack 134 suchthat the bearing 126 is slidable therewith. However, when the bearing126 rotates with the nosecone 118 as described above during actuation ofthe torqueing mechanism 116, the bearing 126 rotates relative to orspins freely within the rack 134. The first and second clips 142A, 142Bthus couple the bearing 126 to the rack 134 such that the bearing 126 isslidable therewith while still permitting the bearing 126 to spin freelyor rotate within the rack 145.

FIG. 13 illustrates a perspective view of the knob 152 removed from thehandle 112 for illustrative purposes only. The knob 152 is accessibleand operable from an exterior of the housing 114. The knob 152 isconcentrically disposed over the rack 134 as best shown in FIG. 14 ,which is a perspective view of an assembly of the rack 134 and the knob152. The knob 152 includes a thread 156 on an inner surface 154 thereofthat is configured to mate with or engage the series of protrusions 140formed on the outer surface 138 of the rack 134. Stated another way, thethreaded inner surface 154 of the knob 152 is threadedly engaged withthe outer surface 138 of the rack 134. More particularly, thread 156 isa continuous helical ridge that wraps around the inner surface of theknob 152. Thread 156, sometimes called a continuous thread or a seriesof threads, has a rounded sinusoidal profile that mates with or engagesthe series of protrusions 140 formed on the outer surface 138 of therack 134. As used herein, a rounded sinusoidal profile of thread 156means that the continuous helical ridge that forms thread 156 has arounded or smooth crown and the windings of the continuous helical ridgecollectively have a sinusoidal or wavelike profile. In alternativeembodiments, the threaded inner surface 138 of the knob 152 can beformed with other thread profiles which mate or engage with the seriesof protrusions 140 formed on the outer surface 138 of the rack 134.

The thread 156 and the series of protrusions 140 formed on the outersurface 138 of the rack 134 are used to convert rotational movement totranslational or linear movement. More particularly, the rack 134 isdisposed within the housing 114 of the handle 112 such that the rack 134is prevented from rotating relative to the housing 114. As shown in FIG.16 , the housing 114 includes a circumferential recess or groove 113formed thereon that is configured to receive the knob 152. An opening115 within the circumferential groove 113 is formed in a sidewall of thehousing 114. The opening 115 permits interaction between the thread 156formed on the inner surface 154 of the knob 152 and the series ofprotrusions 140 formed on the outer surface 138 of the rack 134 as bestshown in the sectional view of FIG. 17 . More particularly, the seriesof protrusions 140 formed on the outer surface 138 of the rack 134extend radially outwards into the circumferential groove 113 of thehousing 114 and mate or engage with the thread 156 of the knob 152.Further, since the series of protrusions 140 formed on the outer surface138 of the rack 134 extend through the opening 115 of the housing 114,the walls of the housing 114 that form the opening 115 prevent the rack134 from rotating relative to the housing 114. The walls of the housing114 that form the opening 115 extend on either side of the series ofprotrusions 140 formed on the outer surface 138 of the rack 134, andthus act as a stop or barrier when the rack 134 attempts to rotate. Assuch, because the rack 134 is prevented from rotating relative to thehousing 114 as explained above, and because the knob 152 also does notaxially move due to being disposed within the circumferential groove 113of the housing 114, the rotational movement of the knob 152 is convertedto translational or linear movement of the rack 134 due to the threadedrelationship between the thread 156 and the series of protrusions 140formed on the outer surface 138 of the rack 134. When the knob 152 isrotated in a first direction, i.e., clockwise, the threaded relationshipbetween the knob 152 and the rack 134 results in axial or longitudinalmovement of the rack 134 in a proximal direction. Conversely, when theknob 152 is rotated in a second direction that opposes the firstdirection, i.e., counter-clockwise, the threaded relationship betweenthe knob 152 and the rack 134 results in axial or longitudinal movementof the rack 134 in a distal direction.

As the rack 134 is axially moved back and forth via rotation of the knob152, the bearing 126 is slidable with the rack 134 over the shaft 102via the first and second clips 142A, 142B described above with respectto FIG. 15 . Further, the pull wire 146 is attached to the bearing 126.Thus, rotation of the knob 152 causes axial movement of the rack 134 andthe bearing 126 coupled thereto, thereby tensioning the pull wire 146 tobend the distal portion of the shaft 102. More particularly, FIG. 18illustrates a perspective view of the catheter 100 with the housing 114of the handle 112 removed for illustrative purposes and with the pullwire 146 of the steering mechanism 144 shown in phantom within thecatheter 100. The pull wire 146 has a proximal end 148 attached to thebearing 126 and a distal end 150 attached to a distal portion of theshaft 102. The pull wire 246 is disposed within the central lumen 110 ofthe shaft 102 and the pull wire 146 passes through the elongated slot108 of the shaft 102 such that the proximal end 148 of the pull wire 146is attached to the bearing 126 as best shown in FIG. 19 , which anenlarged view of a portion of FIG. 18 that depicts the pull wire 146exiting from the shaft 102 via the elongated slot 108. In an embodimentdepicted herein, the pull wire 146 is formed from stainless steel and ametal band or ring (not shown) is utilized to attach the distal end 150of the pull wire 146 to the shaft 102. The distal end 150 of the pullwire 146 is attached to the metal band by welding. In another embodimenthereof, the pull wire 146 is formed from KEVLAR or another relativelyhard polymeric material and the polymer material of the distal end 150is reflowed in order to attach the distal end 150 of the pull wire 146to the shaft 102. The distal end 150 of the pull wire 146 mayalternatively be attached to the shaft 102 using other conventionaltechniques, including bonding or adhesive, and it will be understood byone of ordinary skill in the art that the method of attachment dependsupon the material of the pull wire 146.

The pull wire 146 is selectively tensioned via the steering mechanism144 in order to bend the distal end 106 of the catheter. Moreparticularly, rotation of the knob 152 causes axial movement of the rack134 and the bearing 126 coupled thereto as described above. The bearing126 slides relative to the shaft 102 and relative to the nosecone 118during axial movement thereof. Since the pull wire 146 is attached tothe bearing 126, axial movement of the rack 134 and the bearing 126coupled thereto tensions the pull wire 146 to bend or curve the distalportion of the shaft 102. More particularly, when the bearing 126 andthe pull wire 146 attached thereto are proximally retracted via thesteering mechanism 144, the pull wire 146 is placed under tension and adistal portion of the shaft is curved to a radius of curvature. Thedimension of the radius of curvature depends upon the intendedapplication of the catheter 100, the target anatomy for use of thecatheter 100, and/or the size or profile of the catheter 100. In anembodiment in which the catheter 100 is utilized in a transcatheteraortic valve implantation (TAVI) procedure, the radius of curvatureranges between twenty (20) millimeters and sixty (60) millimeters. Inanother embodiment hereof in which the catheter 100 is utilized inneurological applications, the radius of curvature may be as small as0.5 centimeters. The steering mechanism 144 is accessible to a user viathe handle 112 and the curvature of the distal portion of the catheter100 can be changed based on the user manipulating the steering mechanism144 via the knob 152 of the handle 112.

Notably, both the torqueing mechanism 116 and the steering mechanism 144are integrated into the handle 112 such that operation of the torqueingmechanism 116 does not interfere with operation of the steeringmechanism 144 and operation of the steering mechanism 144 does notinterfere with operation of the torqueing mechanism 116. When thesteering mechanism 144 is actuated via rotation of the knob 152, therack 134 and the bearing 126 coupled thereto move axially orlongitudinally relative to the shaft 102 and the nosecone 118 asdescribed above without interfering with the torqueing mechanism. Whenthe torqueing mechanism 116 is actuated via rotation of the nosecone118, the bearing 126 rotates the shaft 102 and rotates relative to orspins freely within the rack 134 as described above without interferingwith the steering mechanism 144. The pull wire 146 attached at itsproximal end to the bearing 126 rotates to the same degree as the shaft102 when the catheter 100 is being torqued via rotation of the nosecone118.

Although the handle 112 as described above includes a bearing (i.e.,bearing 126, 126C) that transmits torque to the shaft 102, it is onlyrequired that the bearing rotate in conjunction or simultaneously withthe shaft 102 but it is not required that the bearing is the componentthat causes rotation of the shaft 102. The bearing need only be slidablerelative to the shaft 102, and must rotate in conjunction with the shaft102. More particularly, in another embodiment hereof, the shaft 102 andthe nosecone 118 may be constructed such that the nosecone 118 is thecomponent that causes rotation of the shaft 102. For example, the radialflange 175 of the strain relief component 170 may be fixed or secured tothe interior of the nosecone 118 such that the strain relief component170, and the shaft 102 secured thereto, rotate with the nosecone 118. Asdescribed above, the nosecone 118 is further coupled to the bearing 126via first and second fingers 124A, 124B such that the bearing 126rotates in conjunction or simultaneously with the nosecone 118.Accordingly, when the shaft 102 and the nosecone 118 are constructedsuch that the nosecone 118 is the component that causes rotation of theshaft, the bearing 126 rotates in conjunction or simultaneously with theshaft 102 since the nosecone 118 is causing rotation of both components.Since the pull wire 146 is attached at its proximal end to the bearing126, the pull wire 146 also rotates with the bearing 126. Stated anotherway, the nosecone 118, the shaft 102, the bearing 126, and the pull wire146 all rotate to the same degree when the user rotates the nosecone118. The pull wire 146 rotates to the same degree as the shaft 102 sothat the pull wire 146 does not interfere with torquing of the catheter100.

With reference to FIG. 31 , one exemplary embodiment is depicted inwhich the shaft 102 and a nosecone 3118 are coupled together such thatthe nosecone 3118 is the component that causes rotation of the shaft102. FIG. 31 is a perspective view of the nosecone 3118 and the shaft102, with the components removed from the handle for illustrativepurposes only. More particularly, the radial flange 175 of the strainrelief component 170 includes opposing tabs 173 and the nosecone 3118includes opposing recesses 3171 that are configured to receive theopposing tabs 173. Via the mating contact between the tabs 173 of thestrain relief component 170 and the recesses 3171 of the nosecone 3118,the strain relief component 170 (and the shaft 102 secured thereto)rotate with the nosecone 3118. It will be apparent to one of ordinaryskill in the art that the connection between the shaft 102 and thenosecone 3118 is exemplary only, and any suitable connection in whichthe shaft 102 is caused to rotate by the nosecone 3118 may be used.

Further, it will be apparent to one of ordinary skill in the art that inanother embodiment hereof, the shaft 102 can be caused to rotate by boththe bearing 126 and the nosecone 118. For example, the shaft 102 may beattached to the nosecone 118 via the radial flange 175 as describedabove such that the nosecone 118 causes rotation of the shaft 102 whilethe bearing 126 is also configured to transmit torque to the shaft 102via sufficient contact between the bearing 126 and the shaft 102 asdescribed herein. Utilizing both the bearing 126 and a connection to thenosecone 118 to rotate the shaft 102 ensures that the shaft 102 rotatessimultaneously with the nosecone 118.

As previously described, a valve relief component may be utilized withthe catheter 100. Turning now to FIG. 20 , a side view of a valve reliefcomponent 2080 that may be utilized with catheter 100 is shown. Thevalve relief component 2080 includes a proximal end 2082 and a distalend 2084. A hub 2090 including a hemostasis valve or seal is disposed atthe proximal end 2082 of the valve relief component 2080. The hemostasisvalve or seal of the hub 2090 may be formed from a flexible materialsuch as silicone and may include a lubricious coating such as paryleneor silicone oil. The hemostasis valve or seal of the hub 2090 isconfigured to passively or actively seal against the shaft 102 when theshaft 102 is disposed therethrough, creating hemostasis.

Distally extending from the hub 2090 is a sheath 2086. The sheath 2086is a tubular or cylindrical element defining a single lumen 2087therethrough. The sheath 2086 is sized to be used with an introducersheath with the lumen 2087 being sized or configured to slidinglyreceive the shaft 102 of the catheter 100, including the distal portionof the shaft 102 having the balloon-expandable prosthesis 101 disposedthereon. The sheath 2086 is of a sufficient length to cover or extendover the full or entire length of the balloon-expandable prosthesis 101in its delivery or compressed configuration, and thus the particularlength of the sheath 2086 may vary depending upon the application andlength of the balloon-expandable prosthesis 101.

The sheath 2086 may be formed of one or more relatively rigid polymericmaterials such as but not limited to nylon. Optionally, the sheath 2086or some portion thereof may be formed as a composite having areinforcement layer incorporated within a polymeric body in order toenhance strength and/or flexibility. Suitable reinforcement layersinclude braiding, wire mesh layers, embedded axial wires, embeddedhelical or circumferential wires, hypotubes, and the like. In oneembodiment, for example, the entire length of the sheath 2086 is formedfrom a reinforced polymeric tube. In an embodiment, the sheath 2086 istranslucent to allow visual inspection of the balloon-expandableprosthesis 101 when the sheath 2086 is disposed thereover. In anotherembodiment, the sheath 2086 may be opaque.

FIG. 21 is a side view of the valve relief component 2080 slidinglydisposed over the shaft 102 of the catheter 100. As previouslydescribed, the catheter 100 includes a handle 112, the shaft 102distally extending from the handle 112, the strain relief component 170concentrically disposed over a portion of the shaft 102 and distallyextending from the handle 112, and the balloon-expandable prosthesis 101disposed on a distal portion of the shaft 102. The valve reliefcomponent 2080 is slidingly disposed over an outer surface of the shaft102. The valve relief component 2080 is slidable relative to the shaft102 of the catheter 100 such that the valve relief component 2080 may beeasily moved along the shaft 102 in a longitudinal direction asindicated by directional arrow 2092. As such, the valve relief component2080 is configured to be selectively disposed over theballoon-expandable prosthesis 101 to protect the balloon-expandableprosthesis 101 during insertion into an introducer sheath (not shown onFIG. 21 ). More particularly, FIG. 22 is a side view of the distalportion of the catheter 100 with the sheath 2086 of the valve reliefcomponent 2080 disposed over the balloon-expandable prosthesis 101. Whenpositioned over the balloon-expandable prosthesis 101, the valve reliefcomponent 2080 reduces or eliminates the external forces that theballoon-expandable prosthesis 101 experiences when loaded through ahemostatic valve of an introducer sheath, as shown in FIG. 23 . FIG. 23is a side view of the distal portion of the catheter 100 as the catheteris being inserted through a hub 2394 of an introducer sheath 2395 withthe valve relief component 2080 disposed over the balloon-expandableprosthesis 101. The hub 2394 of the introducer sheath 2395 includes ahemostasis valve therein as well as a flush port 2396.

For example, in an embodiment, the balloon-expandable prosthesis 101 isa transcatheter aortic valve replacement prosthesis. When such atranscatheter aortic valve replacement prosthesis is inserted into thehub 2394 of an introducer sheath 2395, tissue of the transcatheteraortic valve replacement prosthesis comes in contact with the hemostasisvalve of the hub 2394 of the introducer sheath 2395. The hemostasisvalve of the hub 2394 of the introducer sheath 2395 may impart enoughforce on the transcatheter aortic valve replacement prosthesis to damageand/or displace the transcatheter aortic valve replacement prosthesis.However, when the valve relief component 2080 is positioned over thetranscatheter aortic valve replacement prosthesis, the valve reliefcomponent 2080 protects the transcatheter aortic valve replacementprosthesis from damage or displacement by reducing or eliminating theexternal forces that the transcatheter aortic valve replacementprosthesis experiences when loaded through a hemostatic valve of theintroducer sheath 2395.

After being advanced through the introducer sheath 2395, it is no longerrequired to have the valve relief component 2080 disposed over theballoon-expandable prosthesis 101 at the site of insertion. As such, thevalve relief component 2080 is configured to dock onto the handle 112 ofthe catheter 100 as shown in the side view of the catheter 100 in FIG.24 . More particularly, the strain relief component 170 of the handle112 of the catheter 100 is configured to serve as a docking station forthe valve relief component 2080 when the valve relief component 2080 isnot disposed over the balloon-expandable prosthesis 101. As describedabove with respect to FIGS. 8A and 8B, the distal end 176 of the strainrelief component 170 extends or protrudes from a distal end of thehousing 114 of the handle 112 and includes the raised ring 177. Thevalve relief component 2080 is secured or docked onto the raised ring177 of the strain relief component 170 through an interference fitbetween the raised ring 177 and the inner surface of the valve reliefcomponent 2080. The torqueing mechanism 116 and the steering mechanism144 may still be actuated via the nosecone 118 and the knob 152,respectively, when the valve relief component 2080 is docked or securedonto the strain relief component 170. After being docked onto the strainrelief component 170, the valve relief component 2080 does not freelyslide along the catheter 102 which may be bothersome to the user.

When performing a procedure, a guidewire (not shown) may be advancedintravascularly using any number of techniques and the introducer sheath2395 is advanced along the guidewire. The catheter 100 is then loadedover the guidewire. The valve relief component 2080 is slid or movedlongitudinally over the shaft 102 of the catheter until the sheath 2086of the valve relief component 2080 covers the balloon-expandableprosthesis 101. With the valve relief component 2080 covering theballoon-expandable prosthesis 101, the valve relief component 2080 andthe distal portion of the catheter 100 are distally advanced through thehub 2394 of the introducer sheath 2395. In an embodiment, the hub 2394of the introducer sheath 2395 includes a stop (not shown) therein toalert the user that the valve relief component 2080 is inserted asufficient depth into introducer sheath 2395. More particularly, thestop alerts the user that the balloon-expandable prosthesis 101 hasentirely passed through the hemostasis valve of the introducer sheath2395 and prevents the user from further inserting the valve reliefcomponent 2080. In an embodiment, the stop may be an integral flange orstep formed on the inner surface of the hub 2394 of the introducersheath 2395, the flange or step having a smaller diameter than an outerdiameter of the valve relief component 2080. After the valve reliefcomponent 2080 contacts the stop within the hub 2394 of the introducersheath 2395, the valve relief component 2080 may be slid along the shaft102 in a proximal direction and be docked onto the strain reliefcomponent 170 of the handle 112 of the catheter 100.

FIG. 25A illustrates another embodiment of a valve relief component 2580that may be utilized with catheter 100. Similar to the valve reliefcomponent 2080, the valve relief component 2580 includes a proximal end2582 and a distal end 2584. A hub 2590 including a hemostasis valve orseal is disposed at the proximal end 2582 of the valve relief component2580. A flush port 2581 is provided on the hub 2590. The hemostasisvalve or seal of the hub 2590 may be formed from a flexible materialsuch as silicone and may include a lubricious coating such as paryleneor silicone oil. The hemostasis valve or seal of the hub 2590 isconfigured to passively or actively seal against the shaft 102 when theshaft 102 is disposed therethrough, creating hemostasis.

Distally extending from the hub 2590 is a sheath 2586. The sheath 2586is a tubular or cylindrical element defining a single lumen 2587therethrough. The sheath 2586 is sized to be used with an introducersheath with the lumen 2587 being sized or configured to slidinglyreceive the shaft 102 of the catheter 100, including the distal portionof the shaft 102 having the balloon-expandable prosthesis 101 disposedthereon. The sheath 2586 is of a sufficient length to cover or extendover the full or entire length of the balloon-expandable prosthesis 101in its delivery or compressed configuration, and thus the particularlength of the sheath 2586 may vary depending upon the application andlength of the balloon-expandable prosthesis 101.

The sheath 2586 may be formed of one or more relatively rigid polymericmaterials such as but not limited to polyethylene. Optionally, thesheath 2586 or some portion thereof may be formed as a composite havinga reinforcement layer incorporated within a polymeric body in order toenhance strength and/or flexibility. Suitable reinforcement layersinclude braiding, wire mesh layers, embedded axial wires, embeddedhelical or circumferential wires, hypotubes, and the like. In oneembodiment, for example, the entire length of the sheath 2586 is formedfrom a reinforced polymeric tube. In this embodiment, the sheath 2586 isopaque. In another embodiment, the sheath 2586 is translucent to allowvisual inspection of the balloon-expandable prosthesis 101 when thesheath 2586 is disposed thereover.

Similar to the valve relief component 2080, the valve relief component2580 is slidable relative to the shaft 102 of the catheter 100 such thatthe valve relief component 2580 may be easily moved along the shaft 102in a longitudinal direction. As such, the valve relief component 2580 isconfigured to be selectively disposed over the balloon-expandableprosthesis 101 to protect the balloon-expandable prosthesis 101 duringinsertion into an introducer sheath. More particularly, FIG. 25B is aside view of the distal portion of the catheter 100 with the sheath 2586of the valve relief component 2580 disposed over the balloon-expandableprosthesis 101. When positioned over the balloon-expandable prosthesis101, the valve relief component 2580 reduces or eliminates the externalforces that the balloon-expandable prosthesis 101 experiences whenloaded through a hemostatic valve of an introducer sheath as describedabove with respect to the valve relief component 2080.

After being advanced through an introducer sheath, it is no longerrequired to have the valve relief component 2580 disposed over theballoon-expandable prosthesis 101. As such, as described above withrespect to the valve relief component 2080, the valve relief component2580 is configured to dock onto the handle 112 of the catheter 100 asshown in the side view of the catheter 100 in FIG. 25C.

The strain relief component 170 of the handle 112 of the catheter 100 isshown removed from the catheter for illustrative purposes in FIG. 26 .As described above, the strain relief component 170 is a relativelyshort tubular component that defines a lumen therethrough that extendsfrom the proximal end 174 to the distal end 176 thereof. The proximalend 174 includes the radial flange 175 that is configured to attach tothe interior of the nosecone 118 (not shown in FIG. 26 ). The distal end176 of the strain relief component 170 extends or protrudes from adistal end of the housing 114 of the handle 112 and includes the raisedring 177 that is configured to provide an interference fit with thevalve relief component 2080, 2580. The valve relief component 2080, 2580is disposed over the tubular body of the strain relief component 170with the raised ring 177 contacting an inner surface of the valve reliefcomponent 2080, 2580. As described herein, the strain relief component170 is configured to serve as a docking station for the valve reliefcomponent 2080, 2580 when the valve relief component 2080, 2580 is notdisposed over the balloon-expandable prosthesis 101. The valve reliefcomponent 2080, 2580 is secured or docked onto the raised ring 177 ofthe strain relief component 170 through an interference fit.

The strain relief component 170 may have alternative configurations toreceive and secure the valve relief component 2080, 2580 thereon. Forexample, a strain relief component 2770 that may be used in embodimentshereof is shown in FIG. 27 . The strain relief component 2770 has aproximal end 2774 and a distal end 2776 thereof. The proximal end 2774includes the radial flange 2775 that is configurated to attach to theinterior of the nosecone 118 (not shown in FIG. 27 ). First and secondtabs 2794A, 2794B distally extend or protrude from the radial flange2775. First and second tabs 2794A, 2794B each include a rounded tip2795A, 2795B, respectively, at a distal end thereof that are configuredto provide an interference fit with the valve relief component 2080,2580. The valve relief component 2080, 2580 is disposed over the firstand second tabs 2794A, 2794B with the rounded tips 2795A, 2795Bcontacting an inner surface of the valve relief component 2080, 2580.The strain relief component 2770 is configured to serve as a dockingstation for the valve relief component 2080, 2580 when the valve reliefcomponent 2080, 2580 is not disposed over the balloon-expandableprosthesis 101. The valve relief component 2080, 2580 is secured ordocked onto the first and second tabs 2794A, 2794B of the strain reliefcomponent 2770 through an interference fit with the rounded tips 2795A,2795B. The strain relief component 2770 is configured to beconcentrically disposed over a portion of the shaft 102 at a distal endof the housing 114 and configured to function to relieve stress from theshaft 102 as it exits from the distal end of the housing 114.

In another example, a strain relief component 2870 that may be used inembodiments hereof is shown in FIG. 28 . The strain relief component2870 has a proximal end 2874 and a distal end 2876 thereof. The proximalend 2874 includes the radial flange 2875 that is configurated to attachto the interior of the nosecone 118 (not shown in FIG. 28 ). A pluralityof prongs 2896 distally extend or protrude from the radial flange 2875and are configured to receive the valve relief component 2080, 2580.Each prong 2896 includes a tang 2897 that extends radially inward at adistal end thereof. The valve relief component 2080, 2580 is disposedwithin the prongs 2896, with the tangs 2897 contacting an outer surfaceof the valve relief component 2080, 2580. The tangs 2897 are configuredto provide an interference fit with the valve relief component 2080,2580. The strain relief component 2870 is configured to serve as adocking station for the valve relief component 2080, 2580 when the valverelief component 2080, 2580 is not disposed over the balloon-expandableprosthesis 101. The valve relief component 2080, 2580 is secured ordocked into the plurality of prongs 2896 of the strain relief component170 through an interference fit with the tangs 2897 of the plurality ofprongs 2896. The strain relief component 2870 is configured to beconcentrically disposed over a portion of the shaft 102 at a distal endof the housing 114 and configured to function to relieve stress from theshaft 102 as it exits from the distal end of the housing 114.

In another example, a strain relief component 2970 that may be used inembodiments hereof is shown in FIG. 29 . The strain relief component2970 has a proximal end 2974 and a distal end 2976 thereof. The proximalend 2974 includes the radial flange 2975 that is configurated to attachto the interior of the nosecone 118 (not shown in FIG. 29 ). First andsecond planar spring elements 2998A, 2998B distally extend or protrudefrom the radial flange 2975 and are configured to receive the valverelief component 2080, 2580. First and second planar spring elements2998A, 2998B are each shape set into the configuration shown on FIG. 29, and resiliently return to their shape set configuration afterdeformation. The valve relief component 2080, 2580 is disposed withinthe first and second planar spring elements 2998A, 2998B, with the firstand second planar spring elements 2998A, 2998B contacting an outersurface of the valve relief component 2080, 2580. The first and secondplanar spring elements 2998A, 2998B are configured to provide aninterference fit with the valve relief component 2080, 2580. The strainrelief component 2970 is configured to serve as a docking station forthe valve relief component 2080, 2580 when the valve relief component2080, 2580 is not disposed over the balloon-expandable prosthesis 101.The valve relief component 2080, 2580 is secured or docked into thefirst and second planar spring elements 2998A, 2998B of the strainrelief component 170 through an interference fit therewith. The strainrelief component 2970 is configured to be concentrically disposed over aportion of the shaft 102 at a distal end of the housing 114 andconfigured to function to relieve stress from the shaft 102 as it exitsfrom the distal end of the housing 114.

FIG. 30 is a perspective view of another configuration of a magneticcoupling that may be utilized in embodiments hereof in order to couplethe valve relief component 2080, 2580 to the housing 114 of the handle112. More particularly, a magnetic coupling 3070 includes first andsecond magnetic components 3072A, 3072B, respectively. The firstmagnetic component 3072A is attached to the proximal end 2082, 2582 ofthe valve relief component 2080, 2580, respectively, and the secondmagnetic component 3072B is attached to a distal end of the housing 114of the handle 112. The first and second magnetic components 3072A, 3072Bare operable to selectively and temporarily couple the valve reliefcomponent 2080, 2580 and the handle 112 together. Coupling between thevalve relief component 2080, 2580 and the handle 112 is selectivelyachieved by means of the magnetic force between first and secondmagnetic components 3072A, 3072B. Both first and second magneticcomponents 3072A, 3072B may be formed from a magnetic material, or oneof first and second magnetic components 3072A, 3072B is formed from amagnetic material and the other is formed from a ferromagnetic material.

While various embodiments according to the present invention have beendescribed above, it should be understood that they have been presentedby way of illustration and example only, and not limitation. It will beapparent to persons skilled in the relevant art that various changes inform and detail can be made therein without departing from the spiritand scope of the invention. For example, the handle having bothtorqueing and steering mechanisms may be utilized in any type ofcatheter device. The catheter device having such a handle may includethe strain relief component and the valve relief components describedherein, or may be used without the strain relief and valve reliefcomponents. Conversely, the strain relief component and the valve reliefcomponents described herein may be incorporated into any type ofcatheter device, including a catheter device having a handle without thetorqueing and steering mechanisms described herein. Thus, the breadthand scope of the present invention should not be limited by any of theabove-described exemplary embodiments, but should be defined only inaccordance with the appended claims and their equivalents. It will alsobe understood that each feature of each embodiment discussed herein, andof each reference cited herein, can be used in combination with thefeatures of any other embodiment. All patents and publications discussedherein are incorporated by reference herein in their entirety.

What is claimed is:
 1. A catheter comprising: a handle; and a shaftextending from within the handle, the handle including a housing; atubular component disposed within the housing and over the shaft; a rackdisposed within the housing and axially movable relative to the housingof the handle, wherein the tubular component is coupled to the rack suchthat the tubular component moves axially with the rack and is rotatablerelative to the rack; and a pull wire having a proximal end attached tothe tubular component and a distal end attached to a distal portion ofthe shaft, wherein axial movement of the rack tensions the pull wire tobend the distal portion of the shaft.
 2. The catheter of claim 1,further comprising an actuator rotatable relative to the housing of thehandle, wherein the tubular component is coupled to the actuator suchthat the tubular component rotates with the actuator and is axiallymovable relative to the actuator.
 3. The catheter of claim 2, whereinthe actuator is a nosecone.
 4. The catheter of claim 2, wherein thenosecone includes first and second fingers proximally extending from aproximal end of the nosecone, and wherein the tubular component iscoupled to the nosecone via the first and second fingers.
 5. Thecatheter of claim 4, wherein the tubular component includes first andsecond slots, the first and second slots being configured to receive thefirst and second fingers proximally extending from the proximal end ofthe nosecone.
 6. The catheter of claim 2, further comprising a lockingmechanism configured to lock a circumferential position of the actuatorrelative to the housing of the handle.
 7. The catheter of claim 6,wherein the locking mechanism includes a slider accessible from anexterior of the housing of the handle, the slider having a pointed tipformed at a distal end thereof that is configured to selectively engageone of a plurality of teeth formed on a proximal end surface of theactuator.
 8. The catheter of claim 2, wherein the tubular component isconfigured to transmit a torque from the actuator to the shaft when theactuator is rotated via a contoured inner surface of the tubularcomponent.
 9. The catheter of claim 8, wherein the contoured innersurface includes a plurality of protrusions.
 10. The catheter of claim9, wherein a tubular component interface is disposed over a portion ofthe shaft, the tubular component interface including a plurality ofgrooves, and wherein the plurality of protrusions are configured to bereceived within the plurality of grooves.
 11. The catheter of claim 10,wherein the plurality of protrusions are permitted to slide within theplurality of grooves.
 12. The catheter of claim 2, wherein rotation ofthe actuator causes an entire length of the shaft to rotate therewith.13. The catheter of claim 2, wherein the shaft and the nosecone arecoupled together such that the nosecone causes rotation of the shaft.14. The catheter of claim 1, wherein the handle further includes a knobrotatable relative to the housing of the handle, and wherein the knobincludes a thread formed on an inner surface thereof and the rackincludes a series of protrusions formed on an outer surface thereof thatare configured to mate with the thread formed on the inner surface ofthe knob, and wherein rotation of the knob causes axial movement of therack and the tubular component coupled thereto.
 15. The catheter ofclaim 1, wherein a radial flange is formed on the tubular component andthe rack includes a clip extending therefrom, the clip being configuredto attach onto the radial flange in order to couple the rack and thetubular component together such that the tubular component moves axiallywith the rack and is rotatable relative to the rack.
 16. The catheter ofclaim 1, further comprising: a balloon-expandable prosthesis disposed ata distal portion of the shaft; a component slidingly disposed over anouter surface of the shaft, the component being configured to beselectively disposed over the balloon-expandable prosthesis to protectthe balloon-expandable prosthesis during insertion into an introducersheath; and a strain relief component concentrically disposed over aportion of the shaft and extending from a distal end of the housing ofthe handle, wherein the strain relief component is configured to serveas a docking station for the component when the component is notdisposed over the balloon-expandable prosthesis.
 17. The catheter ofclaim 11, wherein the shaft includes an elongated slot formed in asidewall thereof, and wherein the pull wire is disposed within a lumenof the shaft and through the elongated slot of the shaft.
 18. A cathetercomprising: a handle; and a shaft extending from within the handle, thehandle including a housing; and a torqueing mechanism disposed at leastpartially within an interior of the housing of the handle, the torqueingmechanism including a nosecone rotatable relative to the housing of thehandle and a tubular component coupled to the nosecone to be rotatabletherewith, wherein the tubular component is disposed over the shaft, asteering mechanism disposed at least partially within the interior ofthe housing of the handle, the steering mechanism including a rack and apull wire having a proximal end attached to the tubular component and adistal end attached to a distal portion of the shaft, wherein the rackis coupled to the tubular component such that the tubular component isslideable therewith, and wherein an entire length of the shaft rotatesin conjunction with the nosecone and the tubular component rotatesrelative to the rack during rotation thereof, and wherein axial movementof the rack tensions the pull wire to bend the distal portion of theshaft and the tubular component slides relative to the shaft andrelative to the nosecone during axial movement thereof.
 19. The catheterof claim 18, wherein the tubular component is configured to transmit atorque from the nosecone to the shaft when the nosecone is rotated. 20.The catheter of claim 18, wherein the shaft and the nosecone are coupledtogether such that the nosecone causes rotation of the shaft.